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The FDA reversed its 2022 NMN ban in September 2025, allowing the $500 million ingredient back on the market after industry pressure and legal challenges
During the 3-year regulatory limbo, unregulated NMN products of questionable quality continued to circulate, creating consumer safety risks
The reversal sets a dangerous "race to market" precedent that could encourage companies to bypass safety protocols for future ingredients
Quality control standards vary wildly, with some NMN products testing at less than 50% purity despite label claims
The supplement industry's most controversial regulatory reversal in recent years has created unprecedented chaos for manufacturers and consumers alike. In September 2025, the FDA officially reversed its November 2022 decision that had excluded nicotinamide mononucleotide (NMN) from the dietary supplement category, ending a three year battle that saw lawsuits, citizen petitions, and millions of dollars in lost revenue. While the decision represents a victory for consumer access and industry advocates, it has exposed critical weaknesses in the regulatory framework and unleashed a flood of quality control challenges that dietary supplement contract manufacturing facilities must now navigate.
The reversal, which came after heavy lobbying from the Natural Products Association and the Alliance for Natural Health, has fundamentally changed how the FDA applies its own rule on precluding drugs. By recognizing that NMN was marketed as a dietary supplement prior to being investigated as a drug, despite the fact that such marketing may have been illegal at the time, the FDA has established a dangerous precedent that encourages manufacturers to bring products to market without adequate safety notices.
During the three years of regulatory uncertainty, NMN never actually disappeared from the market. While major retailers like Amazon pulled products from their platforms, a gray market flourished through independent websites and international suppliers. This underground economy operated without oversight, leading to what industry experts describe as a quality control nightmare. Testing conducted by independent laboratories found that many NMN products circulating during this period contained less than 50% of their labeled potency, with some samples contaminated with heavy metals and undisclosed compounds.
The challenge for legitimate manufacturers like Sawgrass Nutra Labs and others has been distinguishing their quality products from the flood of substandard alternatives. Without clear regulatory enforcement during the ban period, consumers had no reliable way to verify product quality or safety. This created a race to the bottom in pricing, as unscrupulous suppliers undercut legitimate manufacturers who maintained costly quality control protocols.
Now that NMN has returned to legal status, manufacturers face the daunting task of rebuilding consumer trust while competing against established gray market suppliers who gained market share during the ban. The situation is further complicated by the fact that many of these questionable products remain in circulation, creating confusion about quality standards and safety requirements.
The FDA has changed its position on NMN supplement classification but major regulatory obstacles continue to exist. Every company marketing NMN must still submit a New Dietary Ingredient Notification (NDIN) unless they source from a supplier who has already filed one. The requirement creates multiple compliance obligations which manufacturers now find difficult to manage. The FDA has established that companies must complete safety assessment work and clinical information development to meet NDIN requirements because self-affirmed GRAS status cannot serve as an alternative.
The NDIN process for NMN is particularly challenging because of the ingredient's complex synthesis and purification requirements. Unlike botanical ingredients that can rely on historical use data, NMN is a synthesized compound that requires extensive analytical testing to verify identity, purity, and consistency. Manufacturers must demonstrate that their specific production methods yield a safe product, which often requires costly stability studies and contamination testing.
Legal experts warn that the current regulatory environment creates significant litigation risk. The Supreme Court's Loper Bright decision eliminated judicial deference to agency interpretations, meaning courts may scrutinize the FDA's reversal more closely in potential legal challenges. Companies marketing NMN without proper NDIN submissions remain vulnerable to both FDA enforcement actions and competitor lawsuits, creating a minefield of legal exposure.
The technical challenges of producing pharmaceutical grade NMN add another layer of complexity to the post reversal landscape. NMN is inherently unstable, degrading rapidly when exposed to heat, light, or moisture. This instability requires specialized manufacturing equipment, climate controlled facilities, and sophisticated packaging solutions that many contract manufacturers lack. Advanced facilities have invested millions in specialized equipment to maintain product stability, but smaller operations often cut corners to reduce costs.
The synthesis of NMN itself presents quality control challenges. The compound can be produced through various chemical pathways, each yielding different impurity profiles and stability characteristics. Without standardized manufacturing processes or quality specifications, products on the market vary dramatically in their composition and efficacy. Some manufacturers use enzymatic synthesis methods that produce higher purity NMN, while others rely on chemical synthesis that may leave residual solvents or reaction byproducts.
Testing requirements add another layer of complexity and cost. Proper NMN analysis requires high performance liquid chromatography (HPLC) equipment and trained technicians, investments that not all manufacturers are willing to make. The lack of standardized testing methods means that certificates of analysis from different suppliers may not be comparable, making it difficult for brands to verify the quality of their raw materials.
Perhaps the most concerning aspect of the FDA's reversal is the precedent it sets for future ingredients. By accepting that NMN was marketed as a supplement before drug investigations began, even though that marketing may have been unlawful, the agency has essentially rewarded companies that rushed products to market without proper safety assessments. This "race to market" approach incentivizes risky behavior and undermines the premarket notification system that serves as the FDA's primary tool for evaluating supplement safety.
Industry critics, including competitors in the NAD+ precursor space, argue that this decision encourages companies to launch first and worry about compliance later. Carlos Lopez of Niagen, which produces the competing NAD+ precursor nicotinamide riboside, stated that the ruling "perversely incentivizes more unlawful behavior, increasing the likelihood that unsafe products will flood the market."
The implications extend beyond NMN to other ingredients caught between supplement and drug classifications. Companies developing novel compounds now have a roadmap for circumventing the drug preclusion rule: simply ensure products reach market before pharmaceutical investigations begin, regardless of whether that marketing complies with existing regulations.
The global nature of NMN production adds another layer of complexity to quality control efforts. The majority of NMN is synthesized in China, where manufacturing standards and regulatory oversight vary significantly between facilities. During the FDA ban period, Chinese suppliers continued producing NMN for the global market, often without the quality controls required for U.S. dietary supplements. These products continue to enter the U.S. market through various channels, creating unfair competition for domestic manufacturers who maintain higher standards.
Currency fluctuations and trade tensions further complicate the supply chain. The cost of high quality NMN can vary by 300% or more depending on source and purity, creating pressure on manufacturers to find cheaper alternatives. This economic pressure often leads to compromises in quality control, as companies struggle to maintain margins while competing against lower cost imports.
As the dust settles from the FDA's reversal, the supplement industry must grapple with fundamental questions about quality, safety, and regulatory compliance. Leading manufacturers are calling for industry wide standards for NMN production and testing, recognizing that self regulation may be necessary to prevent future regulatory crackdowns. Trade associations are developing certification programs to help consumers identify products that meet quality standards, though participation remains voluntary.
The return of NMN to major retail platforms like Amazon will likely accelerate market growth, with analysts projecting the global NMN market could reach $2 billion by 2030. Consumer confidence needs to be maintained through quality control solutions which address the quality control problems that developed during regulatory uncertainty. The companies which built proper manufacturing facilities and established quality control systems during the ban period now hold an advantage to dominate the market as consumers are becoming more aware of product quality.
The NMN saga demonstrates how dietary supplement regulations face risks of being easily broken. The restoration of consumer access has occurred, yet the fundamental conflicts between pharmaceutical development and supplement marketing continue to exist. The industry needs to handle multiple emerging nutritional and medicinal ingredients as they create new regulatory challenges, which require the industry to maintain its safety standards for protecting consumers. The companies that succeed will be those that prioritize quality and compliance over the race to market mentality that the FDA's reversal inadvertently encourages.
